Study to Determine the Effect of an Anti-IgE Agent on Inflammatory Cells in the Skin of Atopic Dermatitis Patients

• Status: Completed
• Trial end date: 2003-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Elevated levels of immunoglobuline E in blood are said to promote the occurence of atopic dermatitis; in fact, many patients with atopic dermatitis have high IgE levels. This study tried to explore whether the depletion of IgE from blood and skin might result in a change of immunological parameters and might alter the clinical course of the disease.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Omalizumab

Criteria

Inclusion Criteria:

• aged between 12 and 60 years

• clinical diagnosis of AD (criteria of Hanifin and Rajka, 1980)

• serum IgE between 30 and 1,300 IU/ml

• at least one significantly positive RAST

• a positive skin prick test of the same specificity as the RAST

• an Investigator's Global Assessment Score of 2 or more at randomization

• stable AD, as defined as active AD (IGA 2 or more) for > 9 months per year

• signed informed consent.

Exclusion Criteria:

• pregnant or nursing females or women of childbearing potential who did not use a reliable contraceptive method

• treatment with omalizumab within the last 12 months before study treatment

• known hypersensitivity to any ingredients of omalizumab or omalizumab- related drugs

• elevated serum IgE levels for reasons other than atopy

• ongoing immunotherapy

• use of long-acting antihistamine astemizol within 3 months prior to visit1

• use of medium-acting antihistamines (e.g. loratadine, cetirizine) within 5 days prior to visit 1

• use of short-acting antihistamines (e.g. diphenhydramin, terfenadine) within 3 days prior to visit 1

• use of zafirlukast or other leukotriene receptor inhibitors and zileuton or other 5-lipoxygenase enzyme inhibitors within 3 days prior to visit 1

• use of phototherapy or systemic therapy that is known or suspected to have had an effect on AD within 1 month prior to first application of study medication

• treatment with topical therapy (other than hydrocortisone 1%) that is known or suspected to have had an effect on AD within 14 days prior to first application of study medication

• use of systemic steroids (oral, intravenous, including intraarticular and rectal) within one month prior to first application of study medication. (Patients on a stable maintenance dose of inhaled steroids were allowed to participate)

• use of systemic antibiotics within 2 weeks prior to first application of study medication

• use of tranquilizers, hypnotic agents or tricyclic antidepressants within 2 weeks prior to the start of the study

• immunocompromised patients or patients having a history of malignant disease

• concurrent skin diseases

• active bacterial, viral or fungal infections that required treatment with a prohibited medication

• a history of recurrent herpes simplex infection having active lesions at baseline

• tinea corporis / tinea cruris

• clinically significant laboratory abnormalities

• a history of noncompliance to medical regimens and patients who were considered potentially unreliable

• evidence of drug or alcohol abuse or other factors limiting ability to fully cooperate

• any condition or prior/continuing treatment which, in the opinion of the investigator, should have rendered the patient ineligible for the study.